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Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin is determined, AU-007 plus aldesleukin will also be administered with avelumab.
Study details:
This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Part 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the RP2D or maximum tolerated dose (MTD).
The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation cohorts to define RP2D or MTD. In Arm B, AU-007 (Q2w) is evaluated in combination with a single dose of aldesleukin given with the first AU-007 dose. AU-007 is administered Q2w with an escalating single aldesleukin dose in sequential escalation cohorts.
In Arm C, AU-007 is evaluated in combination with aldesleukin, both given Q2w. AU-007 will be administered with an escalating dose of aldesleukin in each sequential Arm C escalation cohort. The Part 2 cohort expansion portion of the study consists of up to three expansion Arms evaluating the initial efficacy of the RP2D from corresponding dose escalation Arms A, B, and C in selected solid tumor types, prioritizing melanoma, renal cell cancer, and non-small cell lung cancer (NSCLC).
Other eligible cancers include but are not limited to head and neck squamous cell carcinoma, urothelial cancer, gastric or gastro-esophageal cancer, and ovarian cancer. Part 3 evaluates the safety of AU-007 in combination with aldesleukin and avelumab, followed by one expansion cohort, in NSCLC.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-04-04
Primary completion: 2025-08-31
Study completion finish: 2025-09-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05267626
Intervention or treatment
DRUG: AU-007
DRUG: Aldesleukin
DRUG: Avelumab
Conditions
- • Advanced Solid Tumor
- • Metastatic Cancer
Find a site
Closest Location:
Southern Oncology Clinical Research Unit
Research sites nearby
Select from list below to view details:
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: AU-007 Monotherapy
| DRUG: AU-007
|
EXPERIMENTAL: AU-007 combined with an aldesleukin loading dose
| DRUG: AU-007
|
EXPERIMENTAL: AU-007 combined with aldesleukin given concomitantly
| DRUG: AU-007
|
EXPERIMENTAL: AU-007 combined with aldesleukin and avelumab given concomitantly
| DRUG: AU-007
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Evaluate the safety and tolerability of AU-007 | Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile | Day 1 thru end of treatment (EOT) visit (28 days after last dose) |
Establish the maximum tolerated dose (MTD) and/or RP2D | With AU-007 alone or in combination with aldesleukin measured by pharmacokinetics (PK), pharmacodynamics (PD), and Biomarkers | Day 1 thru EOT visit (28 days after last dose) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007 | The AUC of AU-007 will be measured at different timepoints after AU-007 administration | Day 1 thru EOT visit (28 days after last dose) |
Magnitude of PK changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007 | The Cmax of AU-007 will be measured at different timepoints after AU-007 administration | Day 1 thru EOT visit (28 days after last dose) |
Magnitude of PK changes in the blood after dosing determined by time of maximum concentration (Tmax) | The Tmax of AU-007 will be measured at different timepoints after AU-007 administration | Day 1 thru EOT visit (28 days after last dose) |
Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007 | The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration | Day 1 thru EOT visit (28 days after last dose) |
Magnitude of cytokine changes in the blood after dosing | Not Specified | Day 1 thru EOT visit (28 days after last dose) |
Magnitude of immunogenicity after dosing with AU-007 alone or in combination with aldesleukin | Assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after AU-007 alone or in combination with aldesleukin | Day 1 thru EOT visit (28 days after last dose) |
Evaluate the preliminary anti-tumor activity of AU-007 alone, in combination with aldesleukin, and in combination with aldesleukin and avelumab in patients with unresectable locally advanced or metastatic cancer | Clinical anti-tumor activity will be evaluated using conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST v1.1. | Day 1 thru EOT visit (28 days after last dose) |
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